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Meta-Analysis
. 2016 Nov 25;11(11):CD005146.
doi: 10.1002/14651858.CD005146.pub3.

Haloperidol plus promethazine for psychosis-induced aggression

Gisele Huf  1 , Jacob Alexander, Pinky Gandhi, Michael H Allen
Affiliations
Meta-Analysis

Haloperidol plus promethazine for psychosis-induced aggression

Gisele Huf et al. Cochrane Database Syst Rev. .

Abstract

Background: Health services often manage agitated or violent people, and such behaviour is particularly prevalent in emergency psychiatric services (10%). The drugs used in such situations should ensure that the person becomes calm swiftly and safely.

Objectives: To examine whether haloperidol plus promethazine is an effective treatment for psychosis-induced aggression.

Search methods: On 6 May 2015 we searched the Cochrane Schizophrenia Group's Register of Trials, which is compiled by systematic searches of major resources (including MEDLINE, EMBASE, AMED, BIOSIS, CINAHL, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings.

Selection criteria: All randomised clinical trials with useable data focusing on haloperidol plus promethazine for psychosis-induced aggression.

Data collection and analysis: We independently extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.

Main results: We found two new randomised controlled trials (RCTs) from the 2015 update searching. The review now includes six studies, randomising 1367 participants and presenting data relevant to six comparisons.When haloperidol plus promethazine was compared with haloperidol alone for psychosis-induced aggression for the outcome not tranquil or asleep at 30 minutes, the combination treatment was clearly more effective (n=316, 1 RCT, RR 0.65, 95% CI 0.49 to 0.87, high-quality evidence). There were 10 occurrences of acute dystonia in the haloperidol alone arm and none in the combination group. The trial was stopped early as haloperidol alone was considered to be too toxic.When haloperidol plus promethazine was compared with olanzapine, high-quality data showed both approaches to be tranquillising. It was suggested that the combination of haloperidol plus promethazine was more effective, but the difference between the two approaches did not reach conventional levels of statistical significance (n=300, 1 RCT, RR 0.60, 95% CI 0.22 to 1.61, high-quality evidence). Lower-quality data suggested that the risk of unwanted excessive sedation was less with the combination approach (n=116, 2 RCTs, RR 0.67, 95% CI 0.12 to 3.84).When haloperidol plus promethazine was compared with ziprasidone all data were of lesser quality. We identified no binary data for the outcome tranquil or asleep. The average sedation score (Ramsay Sedation Scale) was lower for the combination approach but not to conventional levels of statistical significance (n=60, 1 RCT, MD -0.1, 95% CI - 0.58 to 0.38). These data were of low quality and it is unclear what they mean in clinical terms. The haloperidol plus promethazine combination appeared to cause less excessive sedation but again the difference did not reach conventional levels of statistical significance (n=111, 2 RCTs, RR 0.30, 95% CI 0.06 to 1.43).We found few data for the comparison of haloperidol plus promethazine versus haloperidol plus midazolam. Average Ramsay Sedation Scale scores suggest the combination of haloperidol plus midazolam to be the most sedating (n=60, 1 RCT, MD - 0.6, 95% CI -1.13 to -0.07, low-quality evidence). The risk of excessive sedation was considerably less with haloperidol plus promethazine (n=117, 2 RCTs, RR 0.12, 95% CI 0.03 to 0.49, low-quality evidence). Haloperidol plus promethazine seemed to decrease the risk of needing restraints by around 12 hours (n=60, 1 RCT, RR 0.24, 95% CI 0.10 to 0.55, low-quality evidence). It may be that use of midazolam with haloperidol sedates swiftly, but this effect does not last long.When haloperidol plus promethazine was compared with lorazepam, haloperidol plus promethazine seemed to more effectively cause sedation or tranquillisation by 30 minutes (n=200, 1 RCT, RR 0.26, 95% CI 0.10 to 0.68, high-quality evidence). The secondary outcome of needing restraints or seclusion by 12 hours was not clearly different between groups, with about 10% in each group needing this intrusive intervention (moderate-quality evidence). Sedation data were not reported, however, the combination group did have less 'any serious adverse event' in 24-hour follow-up, but there were not clear differences between the groups and we are unsure exactly what the adverse effect was. There were no deaths.When haloperidol plus promethazine was compared with midazolam, there was clear evidence that midazolam is more swiftly tranquillising of an aggressive situation than haloperidol plus promethazine (n=301, 1 RCT, RR 2.90, 95% CI 1.75 to 4.8, high-quality evidence). On its own, midazolam seems to be swift and effective in tranquillising people who are aggressive due to psychosis. There was no difference in risk of serious adverse event overall (n=301, 1 RCT, RR 1.01, 95% CI 0.06 to 15.95, high-quality evidence). However, 1 in 150 participants allocated haloperidol plus promethazine had a swiftly reversed seizure, and 1 in 151 given midazolam had swiftly reversed respiratory arrest.

Authors' conclusions: Haloperidol plus promethazine is effective and safe, and its use is based on good evidence. Benzodiazepines work, with midazolam being particularly swift, but both midazolam and lorazepam cause respiratory depression. Olanzapine intramuscular and ziprasidone intramuscular do seem to be viable options and their action is swift, but resumption of aggression with subsequent need to re-inject was more likely than with haloperidol plus promethazine. Haloperidol used on its own without something to offset its frequent and serious adverse effects does seem difficult to justify.

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Conflict of interest statement

GH: is an author of the included studies (TREC‐Rio‐I; TREC‐Rio‐II) see Potential biases in the review process for more information. No other conflict of interest.

JA: is an author of included studies (TREC‐Vellore‐I; TREC‐Vellore‐II) see Potential biases in the review process for more information. No other conflict of interest.

PG: no conflict of interest.

MHA: Michael was involved in the development of inhaled loxapine with Alexza and continued to work on the 'Phase 4 programme' with Ferrer in Europe. He was also involved in some advisory and educational programme development with Teva around inhaled loxapine. This might be considered an alternative to haloperidol and promethazine in the developed world.

Figures

1
1
Haloperidol structure.
2
2
Promethazine structure.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
5
5
Study flow diagram 2015 update.
1.1
1.1. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.
1.2
1.2. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 2 Tranquil or asleep: 2. Not asleep.
1.3
1.3. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 3 Tranquil or asleep: 3. Time until tranquil or asleep (RSS, high score=good).
1.4
1.4. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 4 Global state: 1. Needing restraints or seclusion.
1.5
1.5. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 5 Global state: 2. Various measures.
1.7
1.7. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 7 Adverse effects: 1. General ‐ Any serious adverse effect.
1.8
1.8. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 8 Adverse effects: 2. Specific ‐ a. Cardiovascular ‐ hypotension.
1.9
1.9. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 9 Adverse effects: 2. Specific ‐ b. Central Nervous System.
1.10
1.10. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 10 Adverse effects: 2. Specific ‐ c. Extrapyramidal problems.
1.11
1.11. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 11 Service outcomes: Not discharged ‐ by 2 weeks.
1.12
1.12. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 12 Specific behaviour: 1. Aggression ‐ a. Other episode of agression.
1.13
1.13. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 13 Specific behaviour: 1. Aggression ‐ b. Average aggression score (OAS ,high score=bad).
1.14
1.14. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 14 Specific behaviour: 1. Aggression ‐ c. Average agitation score (OASS, high score=bad).
1.15
1.15. Analysis
Comparison 1 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL, Outcome 15 Leaving the study early.
2.1
2.1. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.
2.2
2.2. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 2 Tranquil or asleep: 2. Not asleep.
2.3
2.3. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 3 Tranquil or asleep: 3. Never tranquil or asleep during first 4 hours.
2.4
2.4. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 4 Tranquil or asleep: 4. Average sedation score (RSS, high score=good).
2.8
2.8. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 8 Global state: 1. No overall improvement.
2.9
2.9. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 9 Global state: 2. Needing restraints or seclusion.
2.10
2.10. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 10 Global state: 3. Various measures.
2.11
2.11. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 11 Global state: 4. Average improvement (CGI, high score=bad).
2.13
2.13. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 13 Adverse effects: 1. General ‐ Serious adverse effect.
2.14
2.14. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 14 Adverse effects: 2. Specific ‐ a. Cardiovascular ‐ hypotension.
2.15
2.15. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 15 Adverse effects: 2. Specific ‐ b. Central Nervous System ‐ sedation ‐ excessive.
2.16
2.16. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 16 Adverse effects: 2. Specific ‐ c. Extrapyramidal problems ‐ 0‐4 hours.
2.17
2.17. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 17 Specific behaviour: 1. Severe agitation.
2.18
2.18. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 18 Specific behaviour: 2. Average aggression score (OAS, high score=bad).
2.19
2.19. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 19 Specific behaviour: 3. Average agitation score (OASS, high score=bad).
2.20
2.20. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 20 Service outcomes.
2.21
2.21. Analysis
Comparison 2 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ OLANZAPINE, Outcome 21 Leaving the study early.
3.1
3.1. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 1 Tranquil or asleep: 1. Average sedation score (RSS, high score=good).
3.4
3.4. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 4 Global state: 1. Needing restraints or seclusion.
3.5
3.5. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 5 Global state: 2. Additional tranquillising drugs.
3.7
3.7. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 7 Adverse effects: 1. Specific ‐ a. Cardiovascular ‐ hypotension.
3.8
3.8. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 8 Adverse effects: 1. Specific ‐ b. Central Nervous System ‐ excessive sedation.
3.9
3.9. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 9 Adverse effects: 1. Specific ‐ c. Extrapyramidal problems ‐ 0‐4 hours.
3.10
3.10. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 10 Specific behaviour: 1. Severe agitation.
3.11
3.11. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 11 Specific behaviour: 2. Average aggression score (OAS, high score=bad).
3.12
3.12. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 12 Specific behaviour: 3. Average agitation score (OASS, high score=bad).
3.13
3.13. Analysis
Comparison 3 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ ZIPRASIDONE, Outcome 13 Leaving the study early.
4.1
4.1. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 1 Tranquil or asleep: 1. Average sedation score (RSS, high score=good).
4.4
4.4. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 4 Global state: 1. Needing restraints or seclusion.
4.5
4.5. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 5 Global state: 2. Additional tranquilising drugs.
4.7
4.7. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 7 Adverse effects: 1. Specific ‐ a. Cardiovascular ‐ hypotension.
4.8
4.8. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 8 Adverse effects: 1. Specific ‐ b. Central Nervous System ‐ excessive sedation.
4.9
4.9. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 9 Adverse effects: 1. Specific ‐ c. Extrapyramidal problems ‐ 0‐4 hours.
4.10
4.10. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 10 Specific behaviour: 1. Average aggression score (OAS, high score=bad).
4.11
4.11. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 11 Specific behaviour: 2. Average agitation score (OASS, high score=bad).
4.12
4.12. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 12 Specific behaviour: 3. Severe agitation.
4.13
4.13. Analysis
Comparison 4 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM), Outcome 13 Leaving the study early.
5.1
5.1. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.
5.2
5.2. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 2 Tranquil or asleep: 2. Not asleep.
5.4
5.4. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 4 Global state: 1. No overall improvement.
5.5
5.5. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 5 Global state: 2. Needing restraints or seclusion.
5.6
5.6. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 6 Global state: 3. Additional tranquillising drugs.
5.7
5.7. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 7 Global state: 4. Various measures.
5.8
5.8. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 8 Global state: 5. Average improvement (CGI, high score=bad) ).
5.9
5.9. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 9 Adverse effects: 1. General ‐ serious adverse effect.
5.10
5.10. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 10 Adverse effects: 2. Specific ‐ Extrapyramidal problems ‐ 0‐4 hours.
5.11
5.11. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 11 Service outcomes: Not discharged.
5.12
5.12. Analysis
Comparison 5 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ LORAZEPAM, Outcome 12 Leaving the study early.
6.1
6.1. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.
6.2
6.2. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 2 Tranquil or asleep: 2. Not asleep.
6.3
6.3. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 3 Global state: 1. Needing restraints or seclusion ‐ by 2hrs.
6.4
6.4. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 4 Global state: 2. Needing addition drugs during initial phase ‐ by 2hrs.
6.5
6.5. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 5 Global state: 3. Various measures.
6.6
6.6. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 6 Adverse effects: Serious adverse effect.
6.7
6.7. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 7 Service outcomes: Not discharged.
6.8
6.8. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 8 Specific Behaviours: 1. Aggression. a ‐ other episode of aggression ‐ by 24 hrs.
6.9
6.9. Analysis
Comparison 6 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES ‐ MIDAZOLAM, Outcome 9 Leaving the study early.
7.1
7.1. Analysis
Comparison 7 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL ‐ additional 40 minutes data, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.
7.2
7.2. Analysis
Comparison 7 HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC ‐ HALOPERIDOL ‐ additional 40 minutes data, Outcome 2 Tranquil or asleep: 2. Not asleep.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Baldacara 2011 {published data only}
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TREC‐Rio‐I {published data only}
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TREC‐Rio‐II {published data only}
    1. Barbui C. Intramuscular haloperidol plus promethazine is more effective and safer than haloperidol alone for rapid tranquillisation of agitated mentally ill patients. Evidence‐Based Mental Health 2008;11(3):86‐7. - PubMed
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    1. ISRCTN83261243. TREC2 ‐ Rapid tranquillisation for agitated patients in emergency psychiatric rooms in Rio de Janeiro. A randomised trial of intramuscular Haloperidol versus intramuscular Haloperidol + Promethazine. http://www.isrctn.com/ISRCTN83261243 [accessed 7 January 2016].
TREC‐Vellore‐I {published data only}
    1. Alexander J. Lorazepam Versus a Combination of Haloperidol and Promethazine in the Acute Management of Agitation and Aggression ‐ a Randomized Controlled Trial [MD Thesis]. Vellore, India: Christian Medical College, 2003.
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    1. Alexander J, Tharyan P, Adams CE, John T, Mol C, Philip J. Rapid tranquilisation of violent or agitated patients in a psychiatric emergancy setting: a pragmatic randomised trial of intramuscular lorazepam versus haloperidol plus promethazine. British Journal of Psychiatry 2004;185:63‐9. [MEDLINE: ] - PubMed
    1. Tharyan P. A randomised controlled trial of intra‐muscular lorazepam versus intra‐muscular haloperidol+promethazine in the management of psychotic agitations and aggression. http://www.isrctn.com/ISRCTN29863938 [accessed 7 January 2016].
TREC‐Vellore‐II {published data only}
    1. Barbui C. Intramuscular haloperidol plus promethazine is more effective and safer than haloperidol alone for rapid tranquillisation of agitated mentally ill patients. Evidence‐Based Mental Health 2008;11(3):86‐7. - PubMed
    1. NCT00455234. Rapid tranquilization of violent or agitated people in psychiatric emergency settings ‐ a pragmatic randomized controlled trial of intramuscular olanzapine vs intramuscular haloperidol + promethazine. https://www.clinicaltrials.gov/ct/show/NCT00455234 [accessed 7 January 2016].
    1. Nirmal SR. Rapid tranquillization of acutely agitated patients: intramuscular olanzapine vs haloperidol + promethazine ‐ pragmatic randomized control trial. 5th European Congress on Violence in Clinical Psychiatry; 25‐27 October 2007; Amsterdam, the Netherlands. 2007.
    1. Raveendran NS, Tharyan P, Alexander J, Adams CE, Trec‐India II Collaborative Group. Rapid tranquillisation in psychiatirc emergency settings in India: a pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine. BMJ 2007;335(7625):865. - PMC - PubMed
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